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Pharmaceutical companies continue to struggle in India

As we reported in a recent article, pharmaceutical companies are struggling to obtain and enforce patent rights under India’s patent system. In recent weeks two further companies have suffered set-backs.

GlaxoSmithKline (GSK) - Tykerb

Tykerb (Lapatinib ditosylate) is an oral drug sold by GSK for the treatment of breast cancer. In a decision having mixed outcomes for GSK, India’s Intellectual Property Appellate Board (IPAB) considered the validity of two patents following a challenge by New Delhi-based Fresenius Kabi Oncology Ltd (Fesenius). The patents in question are:

IN221017 – claiming lapatinib per se; and

IN221171 – claiming the salt form of lapatinib (i.e., lapatinib ditosylate) used in Tykerb.

Fresenius attacked the patents as being obvious, not enabled and for filing under Section 3(d) of the Indian Patents Act, which prevents patenting of new forms of known drugs that of not have improved therapeutic efficacy.

The IPAB upheld the patent covering lapatinib per se (IN221017), meaning that GSK currently has patent protection for Tykerb in India until 2019. However, the IPAB held that the patent directed to lapatinib ditosylate (IN221171) failed under Section 3(d) and was not an invention. On this basis, the IPAB has revoked this patent, which would have provided protection for GSK until 2021. Thus, GSK has fared better than some pharmaceutical companies in recent times, since they have maintained a degree of patent protection.

Roche - Herceptin

In a case involving a different set of circumstances, three divisional patents held by Roche encompassing trastuzumab (the active ingredient in Herceptin) have been lapsed by the Indian Patent Office. According to the Indian Patent Office, the patents were lapsed because Roche failed to follow proper patent procedures in filing and prosecuting the applications giving rise to the patents. The Indian Patent Office also indicated that Roche was given the opportunity attend a hearing regarding the patents, however chose not to attend.

As with GSK, Roche holds a patent protecting Herceptin and this patent is not affected by the current decision. However, if the divisional patents are not re-instated, Roche will have lost additional patents protecting this blockbuster product. Furthermore, the Indian government has previously reported that it is considering issuing a compulsory license under Roche’s patents to permit production of a biosimilar version of this product. According to the Economic Times, Roche has had some positive news regarding the licensing issue with an application for a compulsory license being refused or delayed, and the Indian Government making enquiries as to whether any company is actually ready to launch a biosimilar version of this product before making a final decision.

Both of these cases highlight that India continues to be a difficult jurisdiction for pharmaceutical companies to obtain enforceable patent protection, and that any company looking to protect such products in India should seek the assistance of experiences legal counsel.